Deep Dive into FDA’s Expedited Programs for Drug Development
If you are developing products for serious and life-threatening illnesses with unmet medical needs, there are several mechanisms offered by…
Deep Dive into FDA’s Expedited Programs for Drug Development
If you are developing products for serious and life-threatening illnesses with unmet medical needs, there are several mechanisms offered by…
Achieve Success for Your US Product Application
The introduction of a new medicinal product to the US market follows a complex process that may extend many years…
FDA Consideration for e-Health
Anastacia Bilek, Ph.D. will share her experience in the regulation of m-Health products as a guide for product developers. She will…
Efficient Drug Development for Promising Medicines: Comparative Introduction to EU & US Regulatory Tools
With a lack of adequate therapeutic options for the great number of patients living with serious diseases, both the EMA…
Preparing a Drug Registration for the US and the EU Parallel or sequential applications –…
This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the…
Preparing a Drug Registration for the US and the EU: Parallel or sequential applications? –…
An overview of the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region…
US & EU Regulations for Drug Delivery Systems: development considerations for innovate products
Marielle Fournier and Anne Dupraz-Poiseau describe US and EU rules governing prefilled syringes, pen injectors and innovative drug-delivery systems for…